Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Oral Irritation Study of Two Experimental Mouthrinses
NCT01156376 · View on ClinicalTrials.gov ↗
Study Summary
This study is 25 days long. People participating in this study will be asked to brush their teeth two times a day. People will be assigned to a mouthwash and will rinse four times a day at the site for five days. A dentist or dental hygienist will look at the mouth, teeth, tongue and gums to make sure the mouthwash does not irritate the mouth. After Day 5 of the study, people will continue to brush two times a day and will return on Day 24 to have their mouth looked at again. People without irritation in their mouth will rinse 4 times a day at the clinical site. People will return to the clinical site the next day and have a final oral exam in which the dentist or dental hygienist will look at the mouth for irritation.
Conditions Studied
Interventions
- DEVICE Potassium Oxalate without Fluoride
- DEVICE Potassium Oxalate with Fluoride
- DEVICE Active Comparator PO-116-A
Study Locations (1)
Indiana
- University Park Research Center (UPRC) — Fort Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2010-06 |
| Est. Completion | 2010-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01156376
The ClinicalTrials.gov registry entry for NCT01156376 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnson & Johnson Consumer and Personal Products Worldwide, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Oral Manifestations appearing as the primary indexed condition, and to 3 interventions — of which Potassium Oxalate without Fluoride is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01156376 reports 1 study location spanning 1 distinct geographic area — top geographies include Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01156376 about?
NCT01156376 is a clinical study titled "Oral Irritation Study of Two Experimental Mouthrinses". This study is 25 days long. People participating in this study will be asked to brush their teeth two times a day. People will be assigned to a mouthwash and will rinse four times a day at the site for five days. A dentist or dental hygienist will look at the mouth, teeth, tongue and gums to make su...
What is the current status of trial NCT01156376?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2010-06. Estimated completion is 2010-07.
What conditions does trial NCT01156376 study?
This clinical trial studies the following conditions: Oral Manifestations. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01156376?
The interventions under investigation include: Potassium Oxalate without Fluoride (DEVICE), Potassium Oxalate with Fluoride (DEVICE), Active Comparator PO-116-A (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01156376?
This trial is sponsored by Johnson & Johnson Consumer and Personal Products Worldwide, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01156376 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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